Product Liability
Warnings and
Instructions
By Kenneth Ross
While the responsibility
of providing adequate
warnings and instructions
should not be taken
lightly, having competent
legal and technical
personnel available
to answer difficult
questions should alleviate
manufacturers’ fears.
Answers to
Some of My
Favorite FAQs
Providing advice on warnings and instructions has occupied a good portion of the last 35 years of my professional
life. First as an in-house lawyer and then as outside counsel, I have tried to provide both legal and practical advice
in this area. Given the lack of law on many
issues involving warnings and instructions, it is impossible simply to offer a legal
opinion and have it provide useful guidance for a manufacturer.
Therefore, those who advise on these
subjects must be prepared to use their
legal knowledge and combine it with practical judgment to provide a realistic set of
options for a manufacturer to use to make
decisions.
DRI has just published a global compendium on the duty to warn, which discusses the law in all 50 states and the
District of Columbia as well as in a number of foreign countries. This will be useful
in understanding the law in these various
areas, especially when you litigate a case
in a particular jurisdiction. But it won’t
be that helpful in making decisions about
warnings and instructions that will be sold
throughout the United States and internationally. Focusing on a particular jurisdiction is not useful when you wish to comply
■ Kenneth Ross is a former partner and now Of Counsel in the Minneapolis office of Bowman and Brooke LLP, where he practices in product safety,
regulatory compliance and liability prevention. He served previously as an
in-house attorney at Westinghouse Electric and Emerson Electric and has
advised on issues involving warnings and instructions for over 30 years.
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© 2012 DRI. All rights reserved.
with the law in all regions in which a product will be sold.
The intent of this article is not to discuss in detail the legal analysis that might
apply to answering certain questions, but
to provide short practical answers to questions that I and others have received and
answered over the years. To the extent that
someone has written on the subject previously, I will provide a link to the more
comprehensive article. I will assume that
a reader understands generally the duty
to warn and is familiar with the applicable American National Standards Institute
(ANSI) standards.
FAQs
Are there guidelines that detail the
process of developing warnings?
ANSI issued a standard dealing with on-­
product warnings in 1991 (ANSI Z535.4)
and how to incorporate safety information
into collateral instructions in 2006 (ANSI
Z535.6). These standards contain guidelines
on how to develop, write and format warnings and instructions. In addition, there are
product-­specific laws and standards that
governments, ANSI and other standards
organizations have issued over the years
that pertain to warnings such as the Federal Hazardous Substances Act, enforced by
the U.S. Consumer Product Safety Commission, for chemicals in consumer products
and ANSI Z400.1/Z129.1-2010 for industrial
chemicals and material safety data sheets.
These product-­specific laws and standards
would take precedence and, therefore, need
to be identified and considered. The ANSI
Z535.4 standard states:
There are a number of existing American National Standards that are recognized for particular industries or
specific uses. Compliance with such a
standard may be considered for the particular industry or use. It is not the
intent of this ANSI Z535.4 standard to
replace existing standards or regulations
that are uniquely applicable to a specific
industry or use.
In addition to ANSI and other U.S. organizations issuing standards, the International Organization for Standardization
(ISO) has issued standards on warnings
and instructions for all products (ISO 3864)
and also for specific product categories
such as ISO 11684 for agricultural equipment, and the European Union has issued
directives on products such as machinery
that contain warnings requirements.
Also, there are various product-­specific
guides that have been created by government agencies for particular product categories. For example, the U.S. Consumer
Product Safety Commission published
“Manufacturer’s Guide to Developing Consumer Product Instructions,” in October
2003; the British Department of Trade
and Industry published an excellent booklet called “Writing Safety Instructions for
Consumer Products” in November 1998;
in 1993, the U.S. Food and Drug Administration (FDA) published “Write it Right:
Recommendations for Developing User
Instruction Manuals for Medical Devices
in Home Health Care,” which incorporates
ANSI Z535 concepts; and the European
Union issued a “Guide to Application of
the Machinery Directive” in June of 2010.
Lastly, if a product has a third-party certification, such as Underwriter’s Laboratory
(UL) or the Canadian Standards Association (CSA), the manufacturer’s labels
and instructions need to comply with the
requirements of that standard.
For some products, there may be multiple laws, regulations, standards and guides
that need to be considered when develop-
ing warnings and instructions. That is one
reason why personnel involved in developing such information need to be familiar
with all of the applicable reference documents that need to be considered. Products
do need to comply with some documents,
and some might just provide helpful guidance. The goal is to use all of the relevant
resources available and be prepared to
defend the adequacy of your process and
your warnings.
For a good overview, see J.P. Frantz, T.P.
Rhoades & M.R. Lehto, “Practical Considerations Regarding the Design and Evaluation of Product Warnings,” in Warnings
and Risk Communication 291–311 (M.S.
Wogalter, D.M. DeJoy, & K.R. Laughery
eds., Taylor & Francis 1999). In addition,
see Shaver & Braun, Is Your Company Using
a Process to Develop Warning Information?,
In-House Defense Quarterly, Summer 2007,
and Ross & Adams, Legally Adequate
Warning Labels: A Conundrum for Every
Manufacturer, For The Defense, Oct. 1998.
Is there a risk in exceeding the voluntary
standards for product labeling applicable
to my product? Is that an admission
that my product is more dangerous than
my competitors, or does this create a
problem for my competitors by providing
warnings that are better than theirs?
The law is clear that mere compliance with
standards is not an absolute defense in
product liability cases. Therefore, you must
meet or exceed the standards. All warnings
can be used to support an argument that a
product is hazardous and allow a plaintiff
to argue that you should have designed the
product to eliminate a hazard rather than
warned purchasers about it. So excessive
warnings can create some problems for
you, especially if you warn about risks that
are very remote or have low severity. This
can also create problems for your competitors in that you have created a “better”
warning that will be compared to your
competitor’s warnings.
It is better for an industry to adopt what
everyone thinks are adequate labels as the
standard. Then, each manufacturer will
comply with the standard and not feel
compelled to do better. With that said, if
an industry does a poor job in developing a standard or does not have a warnings
standard, you should put labels on your
product and provide instructions that you
believe are appropriate for safety and necessary to comply with the law. In addition,
hopefully these also could comply with
ANSI Z535.
What if there are product-specific
laws such as the Federal Hazardous
Substances Act (FHSA) or standards
such as UL’s that conflict with
ANSI Z535.4? Is it imperative that
you also follow ANSI Z535?
There is no evidence that the ANSI Z535.4
formats are superior to other formats or
requirements. It is important to identify
and to try to comply with the more product-­
specific requirements first. But, remember
that the plaintiff can argue that you should
have exceeded the product specific standards and, many times, that would be the
Z535.4 standard. Therefore, if you can also
comply with the Z535.4 standard, so much
the better.
Is there a problem if you select
the wrong signal word?
Z535.4 uses three signal words for injury
related hazards: DANGER, WARNING and
CAUTION. In the Annex to the standard,
there is a detailed process for selecting the
correct signal word. Many manufacturers have been concerned about what could
happen if they select the wrong signal
word, given the definitions in the standard.
The signal word is an attention getter and
also transmits part of the message concerning probability and severity of harm. However, the word message and the pictorial in
the label are more important in communicating the message.
So while it is preferable for a signal
word and a message panel to be consistent, meaning, for instance, that you want
to pair DANGER with “will cause serious
injury or death,” I think that it is unlikely
that a jury would find a warning label
defective if the signal word was wrong.
As long as the word message and the pictorial accurately describe the hazard and
the probability and the severity, the signal
word becomes less important.
With that said, once you determine the
potential severity of harm as being a risk of
serious injury or death, the signal word is
usually going to be WARNING. You would
save DANGER for risks involving a high
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Product Liability
probability (“will”) of harm and, according
to the standard, this signal word should be
limited to the “most extreme situations.”
Do you always need to state the
hazard, consequences and avoidance
procedures even if they are obvious?
The ANSI Z535.4 standard in Annex B
reads:
For some products,
there may be multiple laws,
regulations, standards and
guides that need to be
considered when developing
warnings and instructions.
The word message on a hazard alerting
sign typically communicates information to a viewer on the type of hazard,
the consequence of not avoiding the hazard, and how to avoid the hazard. Many
factors must be considered when determining whether to omit consequence,
avoidance, or type of hazard information in the word message. Factors to consider include whether the message can
be inferred from a symbol, other text
messages, user training, or the context
in which the safety sign is used.
Certainly, it is clear that many hazards
and avoidance procedures can be readily
inferred when a label is on a product and
near the hazard. Studies also support this
view. It has been said that “[f]rom a practical standpoint, this study affirms ANSI
Z535.4’s acknowledgment that people can
infer a variety of information about hazards in the context of product use without
reading explicit statements on a label.” J.P.
Frantz, T.P. Rhoades, R.J. Shah, S.M. Hall,
J.J. Isaacson & C.G Burhans, ANSI Z535
signal words and the ability to infer hazard
and consequence information—1992 versus 2004 in Proceedings of the Human Factors and Ergonomics Society (HFES) 49th
Annual Meeting 1790–94. (HFES 2005).
But you need to be careful about delet-
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ing some of these statements just to save
a little space. If you think that a message
is “obvious” from viewing a product, you
could test that assumption by asking a
small focus group or even just a few people
at your company.
For example, you might delete the avoidance procedure when a product becomes
extremely hot during operation and you
say that there is a burn hazard. To avoid the
burn, you don’t touch the product when it is
operating. That is pretty obvious. The problem is that the product may stay hot for a
while after it is turned off and that will not
be obvious, particularly for a bystander
who didn’t even know that the product had
been in operation.
In addition, you might not warn about
a particular hazard because it is obvious.
For example, you might not warn about a
crush hazard in a conveyor belt. However,
the severity and the probability also have
to be obvious before I would omit a hazard
warning. Taking the crush hazard in a conveyor belt example, it may not be obvious
that a user’s hand can be cut off or crushed,
and the user might just think that his or her
hand could be pinched.
When can you use pictorials instead of
text on labels and in the manual? And
if you do, can you rely on pictorials
without human factors testing?
I have written extensively on this subject. See The Duty to Warn Illiterate and
Non-­English-­Reading Product Users, InHouse Defense Quarterly, Winter 2008,
and Warnings and Instructions: Updated
U.S. Standards and Global Requirements,
DRI Product Liability Committee Newsletter, Fall 2011. Even though this is a complex
subject that is not readily susceptible to a
short answer, I will attempt to provide one.
There are some pictorials that can readily be used in labels in the United States in
place of certain text. Most of them show
the hazard and the consequences and have
been used for decades. Some of them show
the avoidance procedure. One example is
the circle and slash. While many of these
pictorials are very understandable, the general view among most lawyers, including
me, is that, with some exceptions, it is
risky to use no-text labels with only pictorials in the United States. Some messages
are difficult, if not impossible, to trans-
mit with pictorials alone, and a label with
many pictorials really needs to be studied
for a while for a reader possibly to understand the entire message. That defeats the
purpose of a label, which should be understandable at a glance.
One way to use pictorials in lieu of text
is to do human factors testing as described
in ANSI Z535.3. However, such testing is
expensive, and the results may still be challenged by a plaintiff who says that he or she
didn’t understand the pictorial.
The use of no-text labels outside the
United States is much more prevalent and
certainly less of a legal risk. However, a company should consider the likelihood that
products shipped outside the United States
with no-text labels could end up being sold
to consumers in the United States.
Should label and/or manual be tested
for usability and comprehension?
Testing is done very infrequently and in
only very specific circumstances. Most of
the time, a word message is clearly understandable to foreseeable users and does
not need to be tested for comprehension.
If new pictorials are created or a pictorial
is used for a young child or someone with
similar comprehension ability, some testing may be appropriate. When testing is
undertaken for the pictorial, it usually just
tests comprehension and not compliance.
In addition, when we test a pictorial, we can
also test the words to confirm that they are
understandable.
For more information on testing, see
J.P. Frantz, T.P. Rhoades & M.R. Lehto,
“Practical Considerations Regarding the
Design and Evaluation of Product Warnings,” supra, at 305–06, and Ross, Warnings
and Instructions: Updated U.S. Standards
and Global Requirements, supra.
Should labels and manuals in
the United States be bilingual
(English and Spanish)?
Again, this is a very complex issue, and I
have written about it extensively. See The
Duty to Warn Illiterate and Non-­English-­
Reading Product Users, supra, and Multilingual Warnings and Instructions: An
Update, DRI Product Liability Committee
Newsletter, Fall 2012.
However, the quick answer is that the
law does not generally require any lan-
guage other than English. Despite that,
Whether adequacy requires in any given
some retailers do demand at least Spanish
case that warnings be placed directly
on warnings and instructions sold in their
on the product involves a balance of the
stores. Unless there is a customer request,
significance of the hazard, the user’s
a manufacturer should preferably add more
need for the information, the availabilpictorials rather than add a foreign lanity of a feasible means to place the warnguage to try to communicate with non-­
ings on the product, and other factors
English-­reading product users. Once you
in the calculus of risk. If feasible, reaadd a foreign language, you have to decide
son normally suggests that important
which one to add, and then you need to be
warnings be placed on the product itself
sure that the instruction manual is also in
rather than in a pamphlet, booklet, or
that language. And sometimes Spanish is
information sheet that can be damaged,
not the only language that needs to be conlost, destroyed or stuffed in an office
sidered. Lastly, adding other languages will
drawer.… Depending on the circumsometimes diminish the conspicuity of the
stances, however, a warning may still
English message and thereby increase the
be adequate even if it is provided off the
potential liability for English-­reading users
product in a manual or other writing.
who have a hard time finding the English Product Liability Law 601 (2d ed. Thomportion of the message.
son West 2008).
For a more extensive discussion, see my
When can safety messages be in the
article Location of Warnings: On Product
manual and not in the label? When
or in the Manual?, DRI Product Liability
on the label and not in the manual?
Committee Newsletter, Summer 2008. Also
There is very little guidance in the law or see J.P. Frantz, T.P. Rhoades, & M.R. Lehto,
the general warnings standards on these “Practical Considerations Regarding the
questions. Some product-­specific standards, Design and Evaluation of Product Warnincluding UL requirements, do specifically ings,” supra, at 303.
say whether the warning must be on a product or in the manual. Without that require- What about warnings and instructions
ment, it is up to a manufacturer to decide. on component parts that an original
My operating principle is based on an product manufacturer (OEM)
analysis of whether the reader needs to inserts into its final product?
see the information each time that he or An OEM is responsible for providing adeshe uses a product, or whether he or she quate warnings and instructions for its
can read the manual and then refer to that finished product, including all of its cominformation later on as needed. Steve Hall ponents. Therefore, any inadequacies could
from Applied Safety and Ergonomics and result in liability for the OEM. However,
chair of the ANSI Z535.4 subcommittee the component part supplier can also be
responsible for inadequacies in the warnsaid on this question:
There is no hard and fast rule, but gener- ings and instructions provided with its
ally you want to try to provide messages component.
The OEM should try to buy components
in a way that gives people a reasonable
chance to read them at an appropri- from suppliers that appear to have adequate
ate time. So, for tasks that are expected warnings and instructions. Therefore, if a
to involve referring to the manual (e.g., component has warnings, for example, that
assembly, troubleshooting, mainte- do not comply with ANSI Z535.4 or any of
nance, etc.), it is generally reasonable to the other standards, then the OEM should
provide safety messages in the relevant ask the supplier to upgrade the labels. If
part of the manual, and not on a label. the OEM assumes the duty to revise comConversely, for scenarios where the tar- ponent part labels, it could also become liaget audience is not reasonably expected ble for any inadequacies in the warnings.
to have access to a manual, a label may The burden should really be on the supplier to provide adequate information and
be more appropriate.
In addition, Professor David Owen not the OEM.
In the component part purchasing proaddressed this issue in his product liacess, an OEM should provide requirements
bility hornbook:
and guidelines to the component supplier
about how the OEM wants the warnings and
the instructions to appear and be provided.
The OEM will then need to decide if it will
provide the component supplier’s instructions as a separate manual or incorporate
them into the final product manual. If they
are incorporated into the manual, and the
OEM makes changes, the supplier should
approve the final version of the OEM’s manual. And the supplier should indemnify the
OEM in case there are inadequacies in the
supplier’s warnings and instructions.
Let’s change the facts and say that the
component part supplier doesn’t know
how its component will be used, where it
will be placed and where the operator will
be standing in relation to its component.
How can the component part supplier provide warnings and instructions that will
be adequate for all uses and locations? Well
it can’t, and it shouldn’t be required to do
so. But the supplier should have some idea
of the various ways in which its product
can be used and should attempt to provide
some guidance to the OEM on safety information that needs to be incorporated into
the instructions depending on the various
uses that the supplier can anticipate.
The supplier might also provide to the
OEM loose warning labels with instructions on where to place them, depending
on how the component is incorporated into
the final product and where the hazard will
be located for the user. Putting the burden
on the OEM to make the final decision on
the warnings and instructions is appropriate in this situation. Whether you can get
an OEM to take that responsibility depends
on the sophistication of the OEM. If an
OEM doesn’t know what it is doing, then
maybe the component supplier should visit
the OEM’s plant and “approve” the installation of the component and placement of
the warnings.
Do you always need to provide a hard
copy of the instruction manual, or can
you put the manual on a CD and include
it with the product or have a reference
(website link or QR code) on the label to
the manual on the company’s website?
The standards don’t discuss whether a hard
copy instruction manual is required, or
whether the information can be provided
in another way. The reason is probably that
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most manufacturers provide their instructions in a hard copy. However, there have
been manufacturers of certain products
that have recently asked about not providing a hard copy. Instead they want to include the instructions as an electronic file
in a product or in a CD format or just provide on a label a link to the manual on a
website. Examples of such products would
be cell phones, computers, TVs and certain
machinery or equipment run by computers.
I have seen no law that discusses this
issue and since, except as discussed below,
virtually no laws or standards say one way
or another, a manufacturer could omit the
hard copy and argue that what it provided
was adequate under the circumstances.
The ANSI Z535.6 subcommittee has
been discussing the increased use of social
media and company websites and how that
relates to the required instructions. I anticipate that the committee will add some
sections on this subject in the 2016 ANSI
Z535.6 revision. However, for now, the
ANSI Z535.6 standard does mention “supplemental directives,” which could include
references to website links, QR codes and
other recognized types of safety messages.
In Europe, the Guide to the EU Machinery Directive specifically requires that
a hard copy of the manual accompany
machinery. Until the Guide changes, manufacturers of machinery have no other
choice. However, in March 2012, the European Commission approved the use of electronic forms of instructions with certain
medical devices intended for use exclusively by medical professionals.
Manufacturers of active implantable
medical devices, implantable medical
devices, fixed installed medical devices
and medical devices fitted with visual display systems will be able to provide in electronic form use instructions previously
provided on paper.
Manufacturers providing electronic instructions will be required to include notices on product packaging on how to access
the electronic forms of instruction, or provide supplementary printed instructions
on how to access electronic instructions.
Even before the ANSI committee includes
provisions on electronic instructions, manufacturers should consider using new technology to transmit safety information more
effectively and efficiently. The ability to pro-
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vide animations, videos, expanded illustrations and other more interesting ways to
explain how to safely use products should
be considered and utilized when possible.
There is even technology being developed
to allow attaching verbal warning labels to
a product. Vesstech Inc., http://www.vesstech.
com/ (last visited Oct. 1, 2012).
At a minimum, the on-­product warnings should tell a user to read the manual
before using a product and tell the user how
to obtain a replacement manual if one is
missing. This can be done by providing an
800 number to call, an email address of a
company employee, or a website link from
which the user could download a replacement manual.
How do you incorporate safety
information into the company website?
There are several excellent examples of
comprehensive websites that discuss product safety. See Safety.cat.com, Caterpillar,
http://safety.cat.com/ (last visited Oct. 1, 2012),
and Safety Resources, Toro, http://www.toro.
com/en-us/safety/pages/default.aspx (last visited
Oct. 1, 2012). They go well beyond just including links to manuals. They incorporate
videos, interactive manuals and safety tips.
The ANSI Z535.6 subcommittee will be
considering future revisions, which could
discuss how to incorporate safety information into websites. At the moment, there are
no requirements to have extensive safety
information similar to the Caterpillar and
Toro websites mentioned above. However,
to the extent that there is a growth in such
websites, the “state of the art” in safety
websites will be raised and other manufacturers may be inclined to provide much
more information than they currently do.
When should new or improved
warnings and instructions be offered
to prior customers? When do you
need to tell the government?
New and improved warnings and instructions might be considered safety improvements, or they might be considered an
admission that the earlier warnings and instructions were defective. The common law
is clear that manufacturers are not required
to offer safety improvements to prior customers if the earlier product was not defective.
The problem is how do you decide
whether the earlier product might be con-
sidered defective and the new safety information used as evidence to support the
claim? It is a difficult decision and one that
is fraught with potential problems, no matter what you do.
Certainly, if the earlier warnings and
instructions are compliant with the standards and the law and the new versions are
just updated and made a little better, then
it is arguable that these are just improvements. However, if the earlier warnings and
instructions did not comply with the standards or law and were very bad, or if there
have been a number of lawsuits alleging a
failure to warn or several jury verdicts ruling the warnings defective, then the new
warnings and instructions might be more
than just safety improvements.
This is an important analysis where
competent defense counsel can also provide valuable assistance in addition to your
safety counsel. Since you don’t know where
any future case will be brought, it is hard to
know which state’s law to consider. The best
approach is to consult with counsel who
you trust and who is familiar with your
products and your litigation.
Then the question is, in the case of consumer products, do you need to inform
the U.S. Consumer Product Safety Commission, Health Canada or the Australian
authorities about the new warnings and
instructions? The reporting laws are different from country to country, and you
need to consider whether the issuance of
new warnings and instructions to prior
customers could arguably be considered a
“recall” and create a reporting responsibility to any of these agencies. For more information on the reporting requirements, see
Ross, New Safety Laws May Result in Significant New Liability, In-House Defense
Quarterly, Fall 2011.
If customers are not properly using
or maintaining a product and not
following the label or manual, should
you send out a reminder to customers
about the necessity to follow the
instructions and precautions?
In this question, we assume that the earlier
warnings and instructions are adequate.
They just aren’t being followed. This is
always foreseeable. But that doesn’t create
a post-sale duty. However, once we become
aware of this fact and accidents or near
misses have occurred as a result, a postsale duty could arise in some states. See
Ross and Soule, Post-sale Duties: A Minefield for Manufacturers, In-House Defense
Quarterly, Fall 2006.
If accidents have occurred and there is
some way to get the reminder to your customers, it is probably a good idea to do it. If
you can’t find your customers easily, then
maybe placing a reminder on your website
is appropriate.
Of course, a manufacturer may decide
to redesign future products so that there is
less of a hazard when users do not follow
the warnings. In that case, they then have
another difficult decision: whether to retrofit old products with the new designs, such
as a new safety guard, if that is possible.
Your instructions warn users not to
service a product or to perform certain
repairs. But you know that users are
going to do it anyway. What do you do?
When you tell users not to do something but
you know that they will do it anyway, and
there are safe and unsafe ways to do it, then
you might be inclined to tell them how to do
it safely. But then aren’t you “authorizing”
them to do the service or repair that you
don’t really want them to do? On balance,
as long as it is reasonably foreseeable that
they will do the servicing and repairs and
there are hazards in them doing so, then I
would continue to encourage them strongly
not to do it, but then add some basic instructions on how to do it correctly and safely.
One way to handle this is to state that
the repair or the service instructions are for
professional service personnel and not for
the consumer even though the instructions
are contained in the manual that accompanied a product.
Conclusion
There are many other questions that I have
been asked over the years and to which I
have had to supply answers. There is very
little law on these important but narrow
issues. And most of them are not answered
by any of the standards. Despite that, a
manufacturer must consider them and
make a decision.
While designing a safe product is not
an easy task, providing adequate warnings
and instructions is a tough job. It is so easy
to add words, make a label bigger, provide
more illustrations in a manual and do other
things that some jury might believe would
have prevented an accident.
While manufacturers shouldn’t be paralyzed by the fear of not providing adequate
warnings and instructions, they should not
take this responsibility lightly. They should
use competent legal and technical personnel to help, especially on the difficult kinds
of questions represented above.
In addition to providing information that
hopefully will reduce the risk of harm, better warnings and instructions might also
help make a product more marketable in
that it will be perceived by customers to be
easier to assemble, use and maintain. And
they will certainly be easier for defense
counsel to defend if an incident occurs.
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